Senior Director of Quality Assurance
1 week ago
Overview
The Senior Director, Head of Quality Assurance,is responsible forproviding strategic leadership in the development and assurance of compliance with local and global, harmonized Quality Systems from our Research Triangle Park (RTP), North Carolina Location.
In this role, you willserveas memberof the Site Leadership Team (SLT)and the Global Quality Assurance Leadership team. In this role, it is key to achieve site operational goals,definesitequalityaspirations, executive thesite and global QAstrategyas well as contribute to improving thelocal andglobal QA systems.
External US
At FUJIFILM Diosynth Biotechnologies (FDB), an exciting opportunity awaits you to collaborate with some of the most innovative biopharma companies worldwide. Hereyou willhave the chance to learnfrom some of the most dedicated scientists, engineers, and manufacturers who are deeply committed to making an impact on people’s lives.We aredifferent. We strive for better. Our people neversettle for the status quo and as you push the boundaries of your potential, you not only change your life,youchange others’ too.
Join our RTP, NC facility as the Senior Director of Quality Assurance. In this role, you will fully support this facility while being a member of the Global Quality Assurance Organization, implementing the global strategy at the local level. You will ensure adherence to regulatory standards while setting the direction for cGMP compliance and quality assurance, while fostering continuous improvement in the quality culture.
You will lead the quality assurance functions, including Heads of Quality Operations, Quality Systems, Quality Training (Learning) and Supplier Qualification. You will be responsible for all regulatory inspections and interactions, and participation in customer visits and audits in collaboration with the Customer Quality function, all of which are essential to sustaining a viable pharmaceutical business.
Principal Accountabilities:
-
Develops and drives the organization’squality assurance strategy to align with corporate goals and regulatory standardsand ensures readiness for regulatory inspections and customer audits(30%)
-
Leadership of leaders overseeing the varioussiteQuality Assurancefunctionsandleaderof thesite QualityLeadership Team (sQLT).Builds and mentorsa high-performing QA team working locally with the global QA organization in mind ensuring alignment with organizational goals.Ensures that sufficientresourcesare available and thata high levelof trust is built andmaintainedin allpartner relations. Ensures flexible work force to drive development andretaintalent (25%)
-
As a member of the Site Leadership Team (SLT) engaging in the continuous development and expansion of the site through setting leadershipaspirations and through being a rolemodel forthe Fujifilm and the FDB values(15%)
-
Adhere toenterprise-level Key Performance Indicators (KPIs)and additionallyestablishesand innovate actionableKPIsand quality governance processesto ensure continuous and effective continuous improvements of the quality systemacross site and in the global organization (15%)
-
Builds andmaintainsstrong network to key partners internally, globally (sites in US, Denmarkand UK, Customer Quality) as well as external partners and customersas needed(10%)
-
Can include cross functional collaborate and project team leadership assignment consistent with personal strategic, operational and technical leadership (5%)
-
All other duties as assigned
Minimum Education and Experience Requirements:
-
Master'sdegreePharmaceutical Science (preferably in Life Sciences, Pharmaceuticals, or a similar field)
-
10+ years of experience in Quality Assurance in the biopharmaceutical/biotech industry
-
5+ years of leadership experience
Knowledge, Skills and Abilities:
-
Excellent communication skills
-
Excellent problem solving skills
-
Experienced in people development and results driven
-
Excellent project management skills
-
Excellent strategic thinking and influencing
-
Innovative thinker
-
Oriented towards people development and results oriented
-
Conceptual thinking
-
Orientation towards efficiency
In this role there is broad contact across the site, across the global network, towards partners as well as towards regulatory agencies. The scope of the roleincludes contact toMRHA, FDA and other regulatory authoritiesin matters related to product quality. The impact of this position to the site Quality strategy and site leadership strategy is high.
During daily operations as well as during partner auditsand agency inspections the leadership of this role is essential to maintain clarity of direction for the site. The breadthof leadership in this role is large and the influence thereby extensive.
FDBU is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, protectedveteran status, sexual orientation, gender identify or any other protected class. If an accommodation to the application process is needed, please e-mail HR _FDBU@fujifilm.com
To all agencies: Please, no phone calls or emails to any employee of FUJIFILM about this requisition. All resumes submitted by search firms/employment agenciesto any employee at FUJIFILM via-email, the internet or in any form and/or method will be deemed the sole property of FUJIFILM, unless such search firms/employment agencieswere engaged by FUJIFILM for this requisition and a valid agreement with FUJIFILM is in place. In the event a candidate who was submitted outside of the FUJIFILM agencyengagement process is hired, no fee or payment of any kind will be paid.
Job Locations US-NC-Research Triangle Park
Posted Date 3 days ago (1/5/2025 9:24 PM)
Requisition ID 2024-32808
Category Quality Assurance
Company (Portal Searching) FUJIFILM Diosynth Biotechnologies
-
Senior Director of Quality Assurance
4 days ago
Durham, New Hampshire, United States Lonza Full timeQuality Control Leadership Role at LonzaIn this critical leadership position, you will oversee the Quality Control function at Lonza, driving a culture of excellence and regulatory compliance. As the Head of QC, you will lead cross-functional teams to ensure timely delivery of high-quality products while maintaining a strong focus on safety, quality, and...
-
Senior Quality Assurance Specialist
3 weeks ago
Durham, North Carolina, United States MILLENNIUMSOFT Full timeJob Title: Senior Quality Assurance SpecialistEstimated Salary: $70,000 - $90,000 per yearAbout the Job:The Staff Quality Engineer will support the Quality team at our Durham, NC R&D facility to ensure that design history files (DHF) for identified products meet all corporate policies, government regulations, and medical device industry standards for Design...
-
Senior Quality Assurance Manager
4 days ago
Durham, New Hampshire, United States Lonza Full timeJob SummaryThe Senior Quality Assurance Manager will oversee the quality control department to ensure high-quality testing of in-process and final drug product lots, prioritizing safety and professionalism.This role requires creating a disciplined culture while solving complex technical problems and meeting manufacturing demands. With a focus on patient...
-
Quality Assurance Director
4 days ago
Durham, New Hampshire, United States Lonza Full timeAbout LonzaLonza is a global leader in life sciences operating across five continents. We harness the collective power of science to drive innovation and make a meaningful difference in people's lives.Role OverviewThe Associate Director - Head of Quality Control (QC) leads the QC function at our site, implementing a strategy that supports the quality and...
-
Senior Quality Assurance Engineer
6 days ago
Durham, North Carolina, United States Baebies Full timeJob OverviewBaebies is a leading medical device company that develops and commercializes innovative newborn screening and near-patient testing products. Our mission is to enable early disease detection and comprehensive diagnosis, guided by the vision of providing a healthy start for all.We are seeking an experienced Senior Quality Assurance Engineer to join...
-
Senior Quality Assurance Engineer Specialist
4 weeks ago
Durham, North Carolina, United States Baebies Inc. Full timeJob Title:Senior Quality Assurance Engineer SpecialistJob Description:We are seeking a highly experienced and skilled Senior Quality Assurance Engineer to join our team at Baebies Inc. in the medical device industry.About the Role:The Senior Quality Assurance Engineer will be responsible for ensuring compliance with FDA, IVDD, IVDR, and ISO 13485 regulations...
-
Quality Assurance and Compliance Director
4 days ago
Durham, New Hampshire, United States Lonza Full timeJob Description:The Associate Director - Head of Quality Control at Lonza is responsible for leading the QC function to implement strategies that enhance product quality and compliance while achieving operational excellence.About the Role:Oversight of various testing processes, including raw materials, in-process and finished product testing, environmental...
-
Senior Quality Assurance Manager
4 days ago
Durham, New Hampshire, United States Lonza Full timeCompany OverviewLonza is a global leader in life sciences operating across five continents.We work in science, driven by talented people devising ideas that help businesses to help people. In exchange, we let our people own their careers. Their ideas, big and small, genuinely improve the world.About the RoleThe Associate Director -Head of Quality Control...
-
Senior Manager of Assurance Operations
5 days ago
Durham, North Carolina, United States FUJIFILM Corporation Full timeAbout UsFUJIFILM Diosynth Biotechnologies is a leading biopharmaceutical company that provides innovative solutions for the development and manufacturing of biologic therapies. We are committed to delivering high-quality products that meet the needs of our customers and patients.We are seeking a highly experienced Senior Director of Quality Assurance to lead...
-
Durham, United States SpringWorks Therapeutics Full timeJob DescriptionJob DescriptionAbout SpringWorks Therapeutics:SpringWorks is a commercial-stage biopharmaceutical company applying a precision medicine approach to developing and delivering life-changing medicines for people with severe rare diseases and cancer.SpringWorks has a diversified targeted oncology pipeline spanning solid tumors and hematological...
-
Durham, New Hampshire, United States Lonza Full timeRole OverviewThe Associate Director - Head of Quality Control (QC) plays a pivotal role in ensuring high-quality standards and regulatory compliance at Lonza's Portsmouth site. This position involves strategic planning, budget management, and fostering a positive team culture to enhance employee satisfaction and retention. The leader collaborates with...
-
Senior Quality Assurance Engineer
4 weeks ago
Durham, United States Baebies Inc. Full timeJob DescriptionJob DescriptionDescription:Baebies is a medical device company that develops and commercializes newborn screening and near-patient testing products for children and adults to enable early disease detection and comprehensive diagnosis. Guided by the vision that everyone deserves a healthy start," our mission is to save lives and make lives...
-
Senior Quality Assurance Specialist
4 days ago
Durham, North Carolina, United States Comrise Full timeAbout Comrise: We are a dynamic organization dedicated to excellence in quality assurance.">We are seeking an experienced Quality Assurance Specialist to join our team. The ideal candidate will have a comprehensive understanding of quality assurance principles and hands-on experience in laboratory studies, clinical research, and production operations.Key...
-
Quality Assurance Manager
4 weeks ago
Durham, North Carolina, United States Tempus Full timeAbout the RoleTempus is seeking a Senior Supplier Quality Assurance Specialist to play an integral role in supporting quality activities related to Supplier Quality Management (SQM) in accordance with the FDA Quality System Regulation, ISO 13485, and other medical device/IVDR regulations.This individual will also support various QMS activities that comply...
-
Director of Resident Well-being
6 days ago
Durham, North Carolina, United States Phoenix Senior Living Full timeJob Title: Director of Resident Well-beingCompany Overview: Phoenix Senior Living is a leading provider of senior living services, dedicated to delivering high-quality care and support to our residents. We are seeking a seasoned healthcare professional to join our team as a Director of Resident Well-being.Key Responsibilities:Oversee the development and...
-
Quality Assurance Auditor
2 weeks ago
Durham, United States Lonza Full timeQuality Assurance Auditor at Lonza summary: The Associate Director - Head of Quality Control (QC) at Lonza leads the QC function, developing and executing strategies to ensure quality and customer satisfaction while managing a team of professionals. This role involves overseeing testing processes, driving continuous improvement initiatives, and ensuring...
-
Healthcare Leadership Director
3 weeks ago
Durham, North Carolina, United States Phoenix Senior Living Full timeJob Summary: Phoenix Senior Living is seeking a dedicated Healthcare Leadership Director to lead our team in providing exceptional resident care. As a key member of our management team, you will oversee the development and implementation of clinical programs, ensuring compliance with regulatory requirements.The ideal candidate will have a strong background...
-
Quality Assurance Manager
4 days ago
Durham, North Carolina, United States Baebies Full timeAbout BaebiesBaebies is a medical device company dedicated to developing and commercializing innovative newborn screening and near-patient testing products. Our mission is to enable early disease detection and comprehensive diagnosis, guided by the vision that 'everyone deserves a healthy start.'Job PurposeThe Senior Quality Assurance Engineer will be...
-
Senior Quality Assurance Specialist
1 week ago
Durham, United States Humacyte Global, Inc. Full timeDEPARTMENT: Quality LOCATION: Durham, NC; Onsite/Not Remote COMPANY: Humacyte Inc (Nasdaq: HUMA) is developing a disruptive biotechnology platform to deliver universally implantable bioengineered human tissues, advanced tissue constructs, and organ systems designed to improve the lives of patients and transform the practice of medicine. The Company develops...
-
Senior Supplier Quality Assurance Specialist
4 weeks ago
Durham, United States Tempus Full timePassionate about precision medicine and advancing the healthcare industry? Recent advancements in underlying technology have finally made it possible for AI to impact clinical care in a meaningful way. Tempus' proprietary platform connects an entire ecosystem of real-world evidence to deliver real-time, actionable insights to physicians, providing critical...